Drug product
Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Manufactured by: Macleods Pharmaceuticals Ltd., Daman, India NDC# 33342-026-07.
D-0509-2025
Product summary
- Event
- Event 97058
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 9,888/ 30 count bottles
- Official record key
drug-enforcement:D-0509-2025
Official wording
Reason: Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Code information: Lot # 12250247B, Exp. 01/31/2027
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance